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CTRI Number  CTRI/2021/09/037005 [Registered on: 30/09/2021] Trial Registered Prospectively
Last Modified On: 17/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Web-Based Exercise Activity For First Time Mothers With Postpartum Depression 
Scientific Title of Study   Efficacy Of Tele-exercises On Postpartum Depression Among Primiparous Mothers- A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poojitha K 
Designation  Post Graduate Student 
Affiliation  SRM Institute Of Science and Technology 
Address  Room No 134 Physiotherapy OPD SRM College Of Physiotherapy SRM Institute Of Science and Technology SRM Nagar Kattankulathur
Room No 134 Physiotherapy OPD SRM College Of Physiotherapy SRM Institute Of Science and Technology SRM Nagar Kattankulathur
Kancheepuram
TAMIL NADU
603203
India 
Phone  8712750129  
Fax    
Email  pk9898@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  M Anbupriya 
Designation  Assistant Professor 
Affiliation  SRM Institute Of Science and Technology 
Address  Room No 134 PHYSIOTHERAPY OPD SRM College Of Physiotherapy SRM Institute Of Science and Technology SRM Nagar Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9841549219  
Fax    
Email  anbuprim@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  M Anbupriya 
Designation  Assistant Professor 
Affiliation  SRM Institute Of Science and Technology 
Address  ROOM NO 134 PHYSIOTHERAPY OPD SRM College Of Physiotherapy SRM Institute Of Science and Technology SRM Nagar Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9841549219  
Fax    
Email  anbuprim@srmist.edu.in  
 
Source of Monetary or Material Support  
M Anbupriya Assistant Professor SRM College Of Physiotherapy SRM Institute Of Science and Technology SRM Nagar Kattankulathur 
 
Primary Sponsor  
Name  M Anbupriya  
Address  SRM College Of Physiotherapy SRM Institute Of Science and Technology SRM Nagar Kattankulathur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
M Anbupriya  SRM Institute Of Science and Technology  Room number 134 SRM Medical College Hospital and Research Center SRM Institute of Science and Technology SRM Nagar Kattankulathur
Kancheepuram
TAMIL NADU 		 9841549219

anbuprim@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O906||Postpartum mood disturbance,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy care  Advice on brisk physical activity on their own pace at home to be followed for 8 weeks.Pretest will be taken at visit and post test will be taken after 8 weeks 
Intervention  Tele exercise  The tele exercises are an Internet based videoconferencing device (VCD) was installed in each subjects home, allowing real time video and audio communication with the exercise instructor and all other participants. The convenience of an internet-based exercise program could accommodate postpartum women who face many unpredictable time and childcare demands that have limited their attendance at traditional face to face treatment programs. Participants in this study were randomly allocated after screening the eligibility criteria into 2 groups, intervention group & control group & obtain informed consent. A Video conference will be conducted in group or separate sessions. Three sessions will be conducted in a day however based on womens convenience it is mandatory to attend 2 sessions. The intervention group will be performing brisk walking along with warm up & cool down phases. Participants assigned to the intervention were engaged in a 8-week supervised exercise program delivered in 2 sessions per day (each 15 mins), 5days per week.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  42.00 Year(s)
Gender  Female 
Details  Primiparous women both vaginal and caesarean section
Women who scored > 12 on Edinburgh Postnatal Depression Scale EPDS used as a screening tool.
Mothers who understands Tamil & basic English.
Mothers who is willing to give consent
Internet access
 
 
ExclusionCriteria 
Details  Death of the baby, previous preterm birth or miscarriage, history of psychological trauma in the last six months was excluded.
Age <18 years, hypertension, diabetes, or heart disease diagnosed pre-pregnancy or current pregnancy, conceived by in-vitro fertilization.
Currently receiving treatment for depression
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Beck Depressive Inventory scale
Kessler Psychological Distress Scale  		 Pre test for both the scales will be taken at baseline And Post Test will be taken at end of 4th and 8th week  
 
Secondary Outcome  
Outcome  TimePoints 
Pittsburg Sleep Quality Index
Body Dissatisfaction Scale Postpartum Bonding Questionnaire
Work and Social adjustment scale
Breastfeeding Self efficacy Scale 		 At baseline, end of 4th week and 8th week  
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pk9898@srmist.edu.in].

  6. For how long will this data be available start date provided 26-10-2022 and end date provided 26-09-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
       To find the effectiveness of tele-exercises on postpartum depression among primiparous mothers using Beck Depression Inventory Scale for postpartum depression, stress levels by using Kessler Psychological Distress Scale, maternal and infant bonding by using Postpartum Bonding Questionnaire, body figure dissatisfaction after child birth by using Body Dissatisfaction Scale. More evidence-based studies should be added for further studies on postpartum depression and how postpartum depression affects the maternal and infant bonding, how body figure dissatisfaction has effect on postpartum depression and also there is need to investigate what type of exercises, the number and duration of sessions could be mostly benefit people with depression.Systematic review of exercise on prescription schemes found limited evidence on tele-exercises about their effectiveness and recommended further research on postpartum depression.
 
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